Type 1 diabetes is caused by the destruction of pancreatic β cells due to an autoimmune process, which occurs over years. By the time clinical symptoms appear, the mass of β cells is reduced by at least 70-80% (Cnop, M. et al., (2005) Diabetes Dec.; 54 Suppl. 2:S97-107).
A nested PCR diagnostic for diabetes has been developed that detects the relative amount of circulating un-methylated β cell insulin DNA as a result of cell death (Akirav, E. M. et. al., (2011) Proc. Natl. Acad. Sci. 108: 19018-19023). However, nested PCR produces biases and artifacts.
Accordingly, new methods for diagnosing and monitoring type 1 diabetes are needed.